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New treatment option for Advanced Solid Tumor
Official title A Study of YL201 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05434234
What this study is testing
What is YL201?
YL201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF
- Aged ≥18 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
- Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use...
You likely can't join if
- Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of...
- Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy...
- Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if...
- Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
- Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before...
- Received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of...
See the full eligibility criteria
- Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF
- Aged ≥18 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
- Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for...
- Life expectancy of ≥3 months
- Able and willing to comply with protocol visits and procedures
- Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available...
- Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an treatment study
- Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral...
- Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks)
- Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
- Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug
- Received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first...
- Known human immunodeficiency virus (HIV) infection
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study...
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion...
- A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs
- Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose
The study team makes the final eligibility decision.
Where it's taking place
- Fair Oaks, California, United States
- La Jolla, California, United States
- Lone Tree, Colorado, United States
- Washington D.C., District of Columbia, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Santa Fe, New Mexico, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
- Spokane, Washington, United States
- Tacoma, Washington, United States
- Edmonton, Alberta, Canada
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fair Oaks, California, United States; La Jolla, California, United States; Lone Tree, Colorado, United States; Washington D.C., District of Columbia, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.